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Hester Biosciences is redefining definition of smallholder farmer with new sales strategy

BY JOSEPH HARVEY

As the Indian animal health market grows and modernizes, companies are increasingly serving larger corporatized livestock producers. However, Animal Pharm editor Joseph Harvey visited India to meet a company that is developing a sales strategy to take its vaccines to underserved smallholder farmers.

Whilst travelling to Hester Biosciences’ vaccine manufacturing plant on the outskirts of Ahmedabad, examples of backyard farms are inescapable.

The roads leading to the facility are lined with smallholder farms with a scattering of poultry, goats and cattle, while water buffalo are herded freely down busy freeways.

Hester’s focus is presently on poultry vaccines and the majority of its customers run farms with anything between 100,000 and one million birds. However, despite only representing 2-3% of annual revenues, backyard farmers are about to play a more important role in Hester’s future.

“About a year-and-a-half ago, we created a dedicated team to focus on backyard farmers,” stated Hester’s chief executive and managing director Rajiv Gandhi. “We want to have more diverse customers and we have a different portfolio available to backyard farmers including a thermostable Newcastle disease vaccine.”

Mr Gandhi said the cost of the vaccine was immaterial for the farmer, as the vaccine is crucial to the family’s livelihood. “The price of the vaccine is irrelevant to the economy,” he explained. “If the farmer produces even one more egg, then the cost of the vaccine is recovered.”

Hester’s thermostable Newcastle disease vaccine is more expensive than its regular vaccine. The smallholder farms cannot yet afford the cold chain technology to house normal vaccines. However, it is Hester’s plan to change this situation.

As the farm develops a regularly regimen of vaccination and medication, its profit will improve thus giving the farmer the opportunity to expand and improve the cold chain capabilities. This is notwithstanding the urbanization process in India, which would provide villages with electricity to enable the storage of regular vaccines. This will allow the backyard farm to move onto Hester’s regular vaccines and reduce its expenses.

Mr Gandhi believes Hester is itself changing the definition of smallholder farms. The firm said a backyard farm in India tends to have approximately five to 200 birds living in close proximity of the owners. However, Hester’s project is starting to grow the flock size at the farms and elevate the size of even the smallest farms.

Social changeRaj Gera, the company’s vice president of sales and marketing, said Hester has trained around 2,000 local vaccinators who visit local communities to educate backyard farmers. Not only do Hester’s representatives have to teach vaccination methods to these farmers but they also have to detail the diseases that are impacting poultry flocks, such as Gumboro or Newcastle disease.

Mr Gandhi said Hester’s vaccinators have to tackle some sensitive matter when talking to local backyard farmers.

“They may think their birds have died because a curse from the Gods,” he pointed out. “And do they allow outsiders into their village? These are serious social issues we need to tackle. This is not like a typical project.”

Revenue-generating schemeHester is the only Indian animal health company to undertake this type of project. The firm has been working with UK organization GALVmed on this initiative. The partners’ long-term goal is to help smallholder farmers grow their flock size, improve egg production and establish themselves as a self-sustaining business after around two years of guidance.

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Manufacturing plant is key for Hester The key to Hester’s in-house product development is its facility, which is WHO-GMP, ISO 9001:2008, ISO 14001:2004, OHSAS 18001:2007 and GLP certified.It houses over 100 staff and produces the majority of the company’s vaccines and health products.

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Mr Gandhi was keen to point out this is not just a charity project – Hester will gain more revenues as the farms grow and more vaccines are needed. “The farm will grow and improve the farmer’s position,” he stated. “Their economic status will be uplifted. Then there is more profit for the farmer and for Hester.”

“If we help a section of society than that is good,” Mr Gandhi added. “This also increases our visibility in India and helps us create a distribution network.”

India’s vaccine expertiseHester – meaning ‘rising star’ in Persian – has been manufacturing vaccines since 1997, with a core focus on poultry biologicals.

In fact, India as a whole has a very strong veterinary vaccine manufacturing profile. Around 90% of vaccines used in India are manufactured domestically. This sets India aside from other developing nations, which are highly reliant on importing vaccines due to the low quality of locally-produced biologicals.

The country is home to the industry’s usual suspects such as Virbac, which is the largest international player in India. However, India also features home-grown companies such as Hester, Indian Immunologicals, Venky’s and Indovax, with proprietary vaccine sales footprint.

In Hester’s 2015/2016 financial year, it recorded sales of around $15.5 million (+12% year-on-year) and so far the current 12 months is showing a healthy increase in revenues.

The firm has plans to evolve and diversify as it grows its offering from large animals. Poultry vaccines make up 87% of annual revenues through products to protect against Newcastle disease, infectious bronchitis, infectious bursal disease, fowl pox, Marek’s disease, fowl cholera and other diseases.

However, in time, Hester’s large animal products are expected to become its leading business with vaccines for peste des petite ruminants (PPR), goat pox, Brucella abortus, classical swine fever and hemorrhagic septicemia.

While vaccines will always be core to Hester’s product portfolio, the firm is home to an offering of health products for poultry and large animals, which the company also hopes to enlarge. This portfolio currently consists of anti-infectives, antiparasitics, non-steroidal anti-inflammatory drugs, feed supplements and disinfectants.

African visionHester also intends to shift the geographical focus of its revenues in the coming years. “Now we have 10% of sales from exports but, in four years’ time, more than 50% of our sales will come from exports,” said Mr Gandhi. “We want to become a global animal health company. We can do this by looking for joint ventures in emerging markets and growing organically.”

Around 68% of Hester’s exports are to Africa, where the company is actively building a distribution network. To support its expanding international horizons, the firm has established a manufacturing facility in Nepal.

The site, which is about 30km east of Kathmandu, will help Hester complement the vaccine manufacturing done at its WHO GMP site in Ahmedabad. In the week Animal Pharm visited Hester, the Nepal facility begun production of a vaccine for the Nigerian strain of PPR. This strain of the disease is not permitted for manufacture in India.

Mr Gandhi said the company has its first orders for the Nepal facility to supply the PPR vaccine to West Africa as part of a tender process with the FAO. The Nepal facility will also produce the company’s Marek’s vaccine with respins strain.

He also noted: “A manufacturing plant for Africa is key. Ultimately, a region has to have access to its own type of vaccines.”

‘Clear philosophy’Currently, Hester is the second-largest local vaccines firm in India behind poultry product specialist Venky’s.

“We have done all of this all with R&D and no acquisitions,” said Mr Gandhi, who was also a founder of the company. “To make acquisitions and maintain profitability is very difficult. We have a clear philosophy. We want to increase our top line and maintain our bottom line.”

Aside from recent innovations – an infectious bursal disease vaccine, a thermos-stable Newcastle disease vaccine and a freeze-dried probiotic for poultry – Hester has a long roster of ongoing R&D projects, which will diversify its technology offering for its more established customers.

In the coming years, the firm aims to introduce recombinant vaccines, an intranasal PPR vaccine, a thermostable PPR vaccine and proprietary diagnostic tests to its portfolio. The latter is a current priority for the firm said Mr Gandhi, who added: “Before March 2017, we are going to introduce our own diagnostics. This will include certain ELISA kits, PCR kits and conventional diagnostics to complement our vaccine production.”

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Mr Gandhi also said the company intends to branch out into developing its own biomolecules, as well as hormones designed to stimulate superovulation. The latter product presents a particularly lucrative opportunity for Hester as the India government has placed a ban on this type of hormones being imported into India from overseas.

Hester’s work with smallholders, as well as its move into proprietary diagnostics and molecules, marks a first among Indian animal health companies. Is the company of Hester’s size happy taking risks?

Mr Gandhi stated: “We have chosen to be first in these markets and we are okay with risk. Since 1997 we built our foundation and this has given us the power to take us to whatever height is possible.”

Brazil aims to reduce its ‘excessive regulatory bureaucracy’

BY JOSEPH HARVEY

Earlier this year HealthforAnimals’ global benchmarking survey of 2015 revealed major dissatisfaction with Brazil’s regulatory framework for the assessment of veterinary medicines. Animal Pharm editor Joseph Harvey found out how Brazil’s ministry of agriculture, livestock and food supply (MAPA) intends to address these issues.

“Brazil is changing,” stated Barbara Cordeiro, coordinator of veterinary products inspection for MAPA.

Ms Cordeiro was highlighting how Brazil’s complex regulatory system can be detrimental to the access of veterinary medicines in a country with “continental dimensions”.

The largest country in South America currently has over 10,000 veterinary products registered with MAPA, as well as 617 animal health firms active domestically – a congested and competitive space.

However, Ms Cordeiro told delegates to the 5 Global Animal Health Conference in New Delhi, India, there are a number of problems with Brazil’s regulatory framework.

The sheer size of Brazil has been the reason behind some of these issues, she noted. “There has been problems with harmonization between states,” Ms Cordeiro said. “There are many states, all with different characteristics.”

She also said irregularities have also appeared in the standard procedures, regulatory timeframes, the access to regulators with specialist expertise and framework transparency. There has also been pressure caused by the large number of product applications.

Action plan underwayHowever, MAPA is combatting these issues. It is updating Brazilian legislation based on international references like VICH (the trilateral EU-Japan-US program aimed at harmonizing technical requirements) and CAMEVET (American Committee Veterinary Medicinal Products).

Ms Cordeiro said MAPA is not only ready to improve regulatory convergence between Brazil’s many states but also with the country’s international neighbors. The authorities also intend to create predictable and shorter regulatory timeframes, cut down administrative burden, stimulate innovation and provide applicants access to more qualified regulators.

“We are eliminating unnecessary administrative burden,” Ms Cordeiro said. “So, we are not requiring applications for simple changes that have no impact on safety and efficacy. We are increasing the number of auditors available to analyze applications and we are investing in auditors’ qualifications.”

As well as these ongoing initiatives, Ms Cordeiro highlighted the schemes MAPA has already adopted. These include: a regulation proposal to prioritize analysis products deemed to be innovative; the creation of a new coordination department dedicated to pharmacovigilance; and the implementation of an electronic system to analyze registrations.

In fact, Brazil’s fast-track system for innovative products has recently drawn praise from the wider animal health community.

However, despite the steps Brazil has been taking to improve its regulatory framework, Ms Cordeiro said constant challenges will remain: “Regulatory harmonization is essential but to increase the convergence it is necessary to take into account the particular issues among countries. There are different natural characteristics – climactic zones, microorganisms, parasites and breeds. Guidelines will need to have requirements that consider these differences.”

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She concluded by urging a more co-operative and participation approach among Latin American countries to boost regulatory harmonization.

Brazil was not the only country to air its regulatory problems at the conference in Delhi. India also highlighted its need for legislative improvements.

Zoetis widens swine influenza vaccine scope with USDA approval

BY JOSEPH HARVEY

Zoetis has updated its FluSure XP vaccine against swine influenza to include two new H3N2 virus clusters.

The USDA has licensed the updates to the vaccine, allowing Zoetis to tackle the most relevant strains circulating in US herds.

FluSure XP now features the IV-A and IV-B clusters of the H3N2 influenza subtype, which will enable the vaccine to protect herds against the evolving nature of the influenza A virus. Zoetis said the new strains were added based on an ongoing surveillance project with the University of Minnesota’s Veterinary Diagnostic Laboratory.

The USDA license was granted based on studies demonstrating serologic response, as well as research using a virulent H3N2 cluster IV-A strain. The latter study demonstrated protection with a reduction of lung lesions, rectal temperature, nasal shedding and viral titer in bronchoalveolar lavage fluid at necropsy.

The product is a killed vaccine designed to protect swine against respiratory disease caused by swine influenza virus subtypes H1N1, H1N2 and H3N2. Aside from the new additional strains, FluSure XP also protects against H1N1 Gamma and H1N2 Delta-1. FluSure XP is also offered in combination with other Zoetis swine vaccines, including RespiSure and RespiSure-ONE, ER Bac Plus and FarrowSure GOLD.

Zoetis gained US approval for the vaccine under its former guise of Pfizer Animal Health in 2002.

Dr Michael Kuhn, director of US pork technical services at Zoetis, said: “We’ve seen influenza evolve quite rapidly since 1998 when viruses from different species, including humans and birds, began infecting pigs.

“The mixing of genes from different influenza viruses has led to significant changes in how influenza impacts pigs and how the pig’s immune system responds. This is seen even in previously vaccinated animals, particularly if that vaccine did not contain the appropriate subtypes.”

According to Zoetis, swine influenza outbreaks can cost producers more than $10 per pig in medication costs and performance losses.

Merck Animal Health also has a portfolio of swine influenza vaccines. Its MaxiVac Excell 5.0 – an inactivated vaccine against subtype H1N1 and two strains of subtype H3N2 – is marketed in the US, while Harrisvaccines’ H3N2 swine influenza vaccine also has USDA approval. Harrisvaccines is a subsidiary of Merck.

Swedish company Panion signs deal for pet epilepsy therapy

BY JOSEPH HARVEY

Swedish firm Panion Animal Health has gained exclusive rights to develop a gene therapy for epilepsy in companion animals.

Lund-based Panion licensed the rights to the epilepsy drug candidate from its parent company CombiGene.

The deal includes an upfront payment of SwKr3 million ($325,000), which will be paid to CombiGene when Panion receives funding for its operations. This funding is expected in the first quarter of 2017. CombiGene will also receive future royalties from sales of the product.

CombiGene is focused on developing treatments for human neurological disorders. In June 2015, it established a wholly-owned subsidiary called CombiGene Vet to tackle epilepsy in dogs – later renamed Panion Animal Health.

Since then, Panion’s business strategy has been expanded to include the acquisition and in-licensing of rights to animal health applications of ongoing human health development projects.

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CombiGene therapyCombiGene drug candidate has been developed on the basis of discoveries made at Lund University in Sweden and the University of Copenhagen in Denmark. The firm said its treatment consists of an intracranial injection of an adeno-associated virus vector, which is designed to induce the overexpression of neuro-peptide Y (NPY) and the Y2 receptor for NPY.

According to Panion, epilepsy is the most common neurological condition in dogs. The firm said the first-line treatments for canine epilepsy are oral drugs used for human epilepsy.

“Due to differences in absorption, distribution, metabolism and excretion, the antiepileptic drugs used for humans are usually not feasible for dogs,” Panion said. “Unfortunately, for many of these canine epileptic patients, the only alternative if medication does not work is euthanasia, a process which can be emotionally trying for pet owners and their families.”

Applicable marketThe prevalence of canine epilepsy varies from breed to breed. Panion claims epilepsy is reported in 1-5% of dogs.

“In humans, about 30% of epilepsy patients are drug resistant, meaning that despite testing a number of drugs, the efficacy is unsatisfactory or totally absent,” the company explained. “For canine epilepsy too, it is estimated a drug resistance of about 30%.

“Annual drug costs for treating canine epilepsy vary widely, depending on the complexity of the case. Simple drug regimens and monitoring may run up to $500 per year. But, as resistance is encountered, more complex drug regimens and monitoring can increase annual drug cost to $5,000 or more.

“The US is home to 78 million dogs and, assuming a 1% epilepsy prevalence and a 30% drug resistant population, the addressable population is ~234 000 dogs. Pushing the assumptions further to ~2% prevalence, and the addressable population could approach 500,000 dogs in the US alone.”

Panion’s animal health expertisePanion is led by Dr Anja Holm, who is the firm’s chief executive. Her career offers the company a wealth of experience in European regulation of veterinary medicines after she worked for European Medicine Agency’s Committee for Veterinary Medicines for 12 years, including six years as chairperson.

Dr Holm was also senior scientific officer in veterinary medicine for 18 years at the Danish Medicines Agency. She practiced as a veterinarian for four years and participated in a DNA-vaccine research project at the Danish Virus Institute.

Panion’s director of regulatory affairs is Niels-Erik Manniche, who is a practicing veterinarian. He has also spent the last 25 years of his career in the animal health industry, with positions regarding regulatory, clinical trial and pharmacovigilance at MSD Animal Health, Leo Pharmaceuticals Animal Health, Schering-Plough Animal Health, Intervet Danmark, and Pharmacia Denmark Animal Health.

Companion animal products help Zenoaq sales surge in H1

BY DR ATSUO HATA

Japanese animal health firm Nippon Zenyaku Kogyo Company (Zenoaq) reported an 18% increase in sales during the first half of 2016.

The Fukushima-based business posted revenues of ¥15.2 billion ($134.5 million) for the six months ended September 30, 2016.

The firm benefited from strong sales growth of products for companion animals, while its large animal business also recorded a solid display. However, Zenoaq’s poultry products witnessed an 8% decline in sales. The companion animal business is now Zenoaq’s largest segment, overtaking its large animal unit.

The strong display in the first half of 2016 carries on the firm’s high revenue increases recorded in fiscal 2015.

Zenoaq is the second-largest Japanese animal health company and is also ranked 16 in the global Animal Pharm industry rankings.

The company has a particular focus on developing next-generation products for companion animals. According to Zenoaq, pets represent the largest area of product sales in Japan with around 37% of the overall veterinary medicines market in 2015. Pet products (excluding pet food) accounted for ¥41.7 billion ($400 million) of annual revenues last year – a 25% increase over the previous four years.

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As well as its own in-house projects, the firm is working beyond its domestic boundaries with international partners. In May, a collaboration between Nexvet Biopharma and Zenoaq yielded canine-specific monoclonal antibodies.

Zenoaq sales for the first half of 2016 (¥ million)Category First half of 2015 First half of 2016 % changeCompanion animal 5,530 7,450 +34.7

Large animal 6,170 6,580 +6.6

Poultry 900 830 -7.8

Others 293 396 +35.2

Total 12,893 15,256 +18.3Source: Zenoaq

Lack of cohesion assists spread of Rift Valley fever

BY MALCOLM FLANAGAN

Researchers in Sweden claim Rift Valley fever (RVF) outbreaks could intensify in East Africa and Arabian Peninsula because current surveillance systems are not adequate.

Umea University said monitoring systems are unable to detect the RVF virus in livestock before it spreads to humans. The zoonotic disease also has strong potential to spread to previously unaffected countries.

Researchers found that knowledge, attitudes and practices around RVF varied in local communities in affected countries. There were also no existing scientific and veterinary connections between many affected areas and authorities that could limit the impact of RVF outbreaks.

RVF is a viral infection that spreads by mosquitoes and causes mass abortions and death in livestock. The RVF virus can also cause a potentially deadly hemorrhagic fever in humans, for which there are no available treatments or vaccines. Far more deaths are reported in livestock than humans.

Dr Osama Ahmed Hassan and his research colleagues at the Department of Clinical Microbiology, Umea University, found that the ecology of the RVF affected countries in East Africa is conducive for mosquitoes, livestock and human interaction.

The researchers at Umea University and International Centre of Insect Physiology and Ecology in Nairobi, Kenya, said they are developing RVF risk maps on a sub-regional scale that can be used in potential efforts to manage future disease outbreaks. RVF outbreaks usually occur during periods of increased rain which increase the number of mosquitoes.

“Frequent RVF outbreaks occur in Africa and on the Arabian Peninsula. At the moment there is an ongoing outbreak in West Africa. There have also been imported RVF cases reported in Europe and China, which points to the threat and likelihood of a global expansion of the mosquito-borne viral disease,” said Dr Hassan.

“To confront RVF outbreaks we need a policy that better incorporates the local communities, ecological factors and human interactions with livestock and the environment. Our research shows that the best way to combat RVF outbreaks is with a One Health approach.

“Specifically, by this we mean strategies to combat the disease that incorporates knowledge about RVF virus in environment, animals and local communities and also consider socio-cultural and behavioral differences between communities.”

In March 2015, animal health experts said changing environmental conditions could be increasing the spread of vector-borne zoonotic diseases.

Speaking at the International One Health Congress in Amsterdam, the Netherlands, Dr Jean-Jacques Muyembe suggested hotter temperatures could be providing an ideal habitat for vectors such as mosquitoes to flourish and become better established in different geographic locations.

He said environmental changes benefiting the insects are of particular concern to the transmission of zoonoses such as RVF and West Nile virus.

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Pirbright gains new funding for RVF vaccine

BY MALCOLM FLANAGAN

The UK’s Pirbright Institute has been awarded £1.58 million ($1.97 million) for a joint project to develop a safe and effective livestock vaccine against the deadly Rift Valley fever (RVF).

The vaccine development project is a collaboration between Pirbright, the Jenner Institute at the University of Oxford and the International Livestock Research Institute (ILRI) in Nairobi. The new funding comes from the Biotechnology and Biological Sciences Research Council.

Pirbright said the high levels of livestock and human deaths during the last major RVF outbreak in 2006/7 in eastern Africa, highlight the urgency of developing a comprehensive control program against the zoonotic disease.

The RVF livestock vaccines that use live virus are widely distributed in Africa. However, they vary in their effectiveness and have other major drawbacks, such as the need for expensive high containment facilities during production. No licensed vaccines are currently available for humans.

Dr Bryan Charleston, interim director and chief executive of the institute, said: “We will be conducting field trials in Kenya of a new vaccine candidate which has a better safety record than existing vaccines and has been shown to be more effective. In trials, a single-dose provides 100% protection against RVFV challenge in sheep, goats and cattle; outperforming the most widely used licensed livestock RVFV vaccine in Africa.

“This project will address an important disease in Africa and provide a tool to aid the control of disease in countries currently free of RVFV that experience outbreaks either through natural causes or by malicious spread. It highlights the importance of the many national and international partnerships that we have fostered and how these facilitate our work in fighting existing and potential disease threats to the UK and globally.”

Members of the Jenner Institute, based at Pirbright and Oxford, have been working for a number of years on developing a vaccine against RVF. The team for this project will be led by Dr George Warimwe, who is jointly funded by the two organizations.

Dr Warimwe added: “Working with colleagues at ILRI in Nairobi, Kenya, where the disease is endemic, has been very productive and we will build on this successful collaboration. We have also had positive discussions with the regulatory authorities in Kenya regarding field studies with this new vaccine. If successful this would enable us to register and produce the vaccine in this region and potentially pave the way for registration and use in other African countries as well.”

RVF is an emerging global health threat which has been prioritized for vaccine research and development by the World Health Organization and other international health bodies.

RVF is currently restricted to Africa and the Arabian Peninsula and can be transmitted by at least 10 mosquito species that are more widely distributed than RVF is at present. This has led to concern about the potential for further spread of the disease.

Sheep, goats, cattle and camels are highly susceptible to RVF virus infection, which causes high rates of mortality, but the disease can also spread to humans through infectious mosquito bites and contact with RVF-contaminated tissues and fluid. There a greater number of livestock deaths than human ones as result of the disease.

Cipla to divest animal health businessBY JOSEPH HARVEY

Indian drugmaker is in talks to sell its animal health business, according to local media.

Cipla is India’s second-largest pharmaceuticals firm. However, its veterinary medicines business – Cipla Vet – only accounts for around 3% of annual revenues. The firm is currently restructuring its businesses and is selling units that it deems to be non-core.

One rumored suitor for the Cipla animal health business is Alivira Animal Health, which has recently claimed it is the largest Indian veterinary medicines company following a host of global acquisitions.

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The acquisition of Cipla Vet would suit Alivira’s global plans – Cipla Vet is the biggest exporter of veterinary pharmaceuticals with a presence in over 100 countries. It claims to be the first ever Indian company to supply animal health products in highly regulated markets such as the US, Europe, Australia, New Zealand, South Africa, Hong Kong, Turkey, South Korea, Brazil and Mexico.

The company specializes in a wide range of therapeutics for horses, companion animals, livestock, poultry, swine and aquaculture.

New Zealand extends veterinary data protection

BY MALCOLM FLANAGAN

New Zealand’s livestock sector will find it easier to source certain veterinary medicine products after new government legislation was introduced to extend data protection for the animal health and crop protection sectors.

The passing of the Agricultural Compounds and Veterinary Medicines Amendment Act earlier this month increases the protection of research and commercial data required to register animal health and crop protection patents in New Zealand.

New Zealand’s primary sector will now have access to more innovative agricultural products, as well as products for use in minor crops and minor animal species due to the law change increasing data protection time frames.

Increasing this protection from five to 10 years will incentivize manufacturers of veterinary medicines and crop protection products to bring their technology and invest in solutions specifically for New Zealand.

Mark Ross, chief executive of the New Zealand farm industry body Agcarm, said: “This means farmers and growers will soon be able to access more products to farm productively. It will bring much needed veterinary products to farmers of minor species such as deer and goats.

“Manufacturers now have the incentive to develop products specifically for these types of situations. These products undergo extensive testing and research to prove to our regulators that they are suitable for crops and food animals and are sustainable.”

The increase will allow 10 years of protection for innovative products and five years for new uses, new formulations and reassessments.

Agcarm said previously New Zealand had one of the worst data protection regimes in the developed world for animal health and crop protection products. Agcarm has been advocating for an increase in data protection for over 15 years. Agcarm is based in the New Zealand capital Wellington, South Island.

Many countries worldwide are calling for greater data protection for veterinary medicines. Earlier this year, IFAH-Europe suggested to Animal Pharm there is not enough data/intellectual property protection is currently provided for European manufacturers.

EU consolidates measures as H5N8 spreads

BY MAX GREEN

As H5N8 avian flu spreads across the EU, member state experts have backed plans to consolidate measures aimed at protecting against the virus.

Since H5N8 appeared in the bloc in early November, the European Commission has published eight separate implementing decisions outlining protective measures first in Hungary, then in Germany, Austria, the Netherlands, Denmark and Sweden.

With new cases surfacing in previously unaffected areas – France has begun reporting outbreaks – the EU executive tabled a consolidated draft legal text at a Standing Committee meeting this week. A favorable opinion from the committee paves the way for the plans to be adopted in the near future.

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“The Commission has reacted promptly to this situation, and though the virus is still predominantly a bird virus without any specific increased affinity for humans, I call on Member States authorities, and the poultry sector, for extreme vigilance over this virus, and in particular the stepping up of biosecurity on poultry farms, “ said EU Health Commissioner Vytenis Andriukaitis.

Market impactsMeanwhile, a new Rabobank report said the wave of new avian flu outbreaks has the potential to shake up global market conditions in 2017 – both in the meat trade and breeding stock trade.

It notes that the resurgence of avian flu comes just as the industry had started reporting better results – with strong market balances in most regions and ongoing low costs.

“Global trade streams will be heavily influenced by the new wave of global AI outbreaks in Europe, Asia and Africa and this could highly affect global markets in 1H 2017, with Brazil and Thailand probably emerging as winners,” the Dutch bank said.

As it seems that avian flu is now endemic in wild birds, Rabobank said the disease has become more of a business risk – meaning companies need to adjust for it in their business model.

“This means more regional and international operations (both in breeding and commercial poultry production), optimal biosecurity and a very active and cooperative role of government and industry, with ongoing monitoring, culling and temporary indoor housing,” the report added.

Max Green is the Meat and Livestock Editor for Agra Europe, a sister publication of Animal Pharm.

Bimeda buys rights to Ceva US equine assets

BY JOSEPH HARVEY

Bimeda has strengthened its selection of equine products in the US by acquiring marketing rights to Ceva Animal Health’s horse portfolio.

The US branch of Ireland-headquartered Bimeda is making a strategic expansion in the North American equine market. The firm gains US rights to: Tildren (tiludronate disodium), a lameness treatment; a generic altrenogest for the control of mare estrus; ConfidenceEQ, a gel-based pheromone used to help horses cope with stress; and PentosanEQ for the replacement of synovial fluid in horses.

The transaction also sees Bimeda acquire the marketing rights for Tildren in Canada from Ceva.

Bimeda, which has US headquarters just outside of Chicago in Oakbrook Terrace, Illinois, will add the Ceva products to its existing cache of equine treatments. These include antiparasitics, anti-inflammatories, antimicrobials, sedatives and hormonal injections.

In North America, Ceva is focused on growing its products in the areas of companion animals, poultry and swine. In 2014, the Lenexa, Kansas-based business formed a new equine division to help target this sector more effectively.

Canadian authorities tackle bTB incidentBY JOSEPH HARVEY

Canadian officials have begun an investigation after the USDA said bovine tuberculosis (bTB) was detected in a cow from Alberta when it was slaughtered in the US.

The Canadian Food Inspection Agency (CFIA) said its investigation has uncovered six confirmed cases of bTB to date, including the cow slaughter in the US. Tracing work is currently underway to identify animals that may have been exposed to bTB at individual premises in Alberta and Saskatchewan.

“All confirmed cases are from one infected herd which is located on 18 premises,” the CFIA stated. “Nearly all adult animals from these herds have been tested and the removal and humane destruction of these animals is continuing.”

There are currently around 40 premises under quarantine and movement controls – most of which are located in Alberta. A total of 22,000 animals have been quarantined by the investigation.

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The agency added: “CFIA inspectors are conducting on-farm testing and tracing of potentially exposed animals. Additional staff has been brought to the region to support the investigation and more will be added shortly.

“As this investigation involves a significant number of herds and requires the tracing of the movement of animals for the past five years plus testing, it is not expected to be completed for several months.”

Authorities said the tuberculosis identified in the first confirmed case is closely related to a strain originating from cattle in central Mexico in 1997.

In Canada, bTB is a reportable disease and all cases must be reported to the CFIA. While the country is considered to be officially free of bTB, isolated cases such as this one may occur. The disease has been subject to a mandatory national eradication program since 1923.

DS Pharma secures solid H1 growthBY DR ATSUO HATA

Japanese firm DS Pharma Animal Health has reported a 3% improvement in its first-half sales.

The Osaka-based company reported revenues of ¥6.4 billion ($56.6 million) for the six months ended September 30, 2016. While the majority of product sales rose for DS Pharma, its aquaculture division saw a 48% decline in revenues.

DS Pharma sales for the first half of fiscal 2016 (¥ million)Product category First half of 2015 First half of 2016 % changeCompanion animal 5,640 5,850 +3.8

Farm animal 430 480 +10.5

Aquaculture 130 70 -47.8

Total 6,200 6,400 +3.2Source: DS Pharma

While the company’s first-half performance is solid, it is down on the 7% increase in sales it reported for fiscal 2015. DS Pharma is the third-largest Japanese animal health company.

Evonik acquires French methionine technology

BY MALCOLM FLANAGAN

German feed additive specialist Evonik Industries has agreed to purchase a technology platform for producing amino acid from France’s METabolic EXplorer (METEX).

The package includes METEX’s entire technology portfolio for the fermentative production of methionine, as well as patents, essential bacteria strains and the InoLa brand.

The total consideration for the transfer of this technology, including a two-year transfer service agreement, amounts to €45 million ($48 million).

The transaction also includes a back license agreement pertaining to certain patents to be transferred to Evonik. This agreement will allow METEX to continue using these patents for activities other than those relating to methionine.

Evonik said “the acquisition of METEX technology will expand its technological leadership for amino acids produced both chemically and by fermentation”.

METEX describes itself as “a green chemistry company that develops and patents innovative, fermentation-based industrial processes. Faced with the disappearance of fossil fuel resources, the company’s processes are opening up new avenues for using natural, sustainable, renewable resources”.

Evonik has found that the food animals need more lysine and methionine than is present in feed made mostly of corn and soybean meal.

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The companies intend to explore the possibility of a research and development cooperation agreement on the development of biotechnologically-produced amino acids. The purchase is expected to close by the end of the year.

METEX considers the agreement will underscore the relevance of METEX’s alternative technologies and will strengthen its ability to commercialize its other technologies.

Amino acids produced by fermentation are an important pillar of Evonik’s product portfolio for sustainable animal nutrition. Production process efficiency for Biolys (lysine), ThreAMINO (threonine) and TrypAMINO (tryptophane) have been continuously improved over the past few years. The portfolio was recently expanded to include ValAMINO (valine).

Dr Emmanuel Auer, head of Evonik’s animal nutrition business, said: “Through its fermentative methionine production process, METEX has demonstrated excellent development work and was able to secure wide-ranging patent protection. The acquisition of this technology will expand our technological leadership for amino acids produced both chemically and by fermentation.

“METEX has many years of experience in the field of strain development and fermentation technology. We believe the potential exists to develop viable process optimization methods for products manufactured using biotechnology in animal nutrition and beyond. This acquisition will complement and broaden Evonik’s technology portfolio for important innovation fields.”

Founded in 1999 and headquartered in the French town of Clermont-Ferrand, METabolic EXplorer is an industrial biochemistry company specializing in the development of biotechnology production processes for bio-based substances used in a wide variety of everyday products such as textile fibers and feed additives.

Benjamin Gonzalez, chief executive of METEX, said: “We have been able to show that our fermentation process for manufacturing methionine is a potential alternative to familiar manufacturing routes. For all of the company’s stakeholders, this is a validation of our technical leadership. Proceeds from the sale will accelerate our ability to further develop and market our other technologies.

“Amino acids are clearly high-value-added products, and we are confident that our expertise will deliver new competitive solutions beyond methionine. Improving processes for key natural products for animal feed is one of our top priorities. We look forward to the possibility of a constructive R&D partnership with Evonik to that effect.”

In July this year, Evonik acquired the probiotics business of Spanish feed additive specialist NOREL. Evonik also gained NOREL’s manufacturing site in León.

The acquisition helped Evonik further expand its product offering beyond its core portfolio of amino acids. Essen-based Evonik is currently growing its animal nutrition portfolio and is “striving to provide innovative solutions for antibiotic-free livestock management”.

The company said probiotics play a key role as a possible alternative to the use of antibiotics and antibiotic growth promotors. Evonik has also been expanding in Asia and Latin America in the last year.

IDT establishes Polish sales subsidiaryBY JOSEPH HARVEY

German veterinary vaccines specialist IDT Biologika has created a sales subsidiary in Poznan, Poland.

The new business will help local veterinarians combat swine diseases on large hog farms by providing access to IDT’s vaccines and consultancy services. The unit is designed to strengthen IDT’s position in the country, as it already sells its vaccines in Poland.

The subsidiary will be led by Dr Jacek Fabczak, who is also IDT’s key account manager in Poland. Dr Robert Panek will serve as the Polish unit’s technical service manager.

IDT said the new subsidiary will target regions where hog farming is concentrated in Poland, including Wielkopolskie, Kujawsko-Pomorskie and Pomorskie in the western part of the country.

IDT’s swine vaccines include: Clostriporc A, a Clostridium perfringens Type A toxoid vaccine; Coliporc, an inactivated Escherichia coli vaccine (with F4, F5, F6 fimbrial antigens); Ecoporc Shiga, a one-shot recombinant toxin vaccine against edema disease caused by Shigatoxin Stx2e-producing E coli; Respiporc Art+EP, an inactivated vaccine against atrophic rhinitis (Pasteurella multocida Type D) and enzootic pneumonia (Bordetella bronchiseptica, Pasteurella multocida Type A); Respiporc Flu3, an inactivated influenza vaccine for H1N1, H3N2 and H1N2; Salmoporc SCS, a live Salmonella cholerae suis marker vaccine; and Salmoporc STM, a live Salmonella typhimurium marker vaccine.

IDT is currently aiming to expand its veterinary vaccines business into the world’s major pig and poultry-producing markets.

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EFSA confirms low incidence of BSE in EU

BY MAX GREEN

A new report from the European Food Safety Authority (EFSA) confirms bovine spongiform encephalopathy (BSE) only affects a handful of cattle in the EU each year.

However, the agency now faces the challenge of finding out why classical BSE cases still crop up at all given that strict control measures have been in place for the past 15 years.

Published recently, EFSA’s summary for 2015 reveals that just five BSE cases were detected in the EU out of 1.4 million animals tested. These cases were all among fallen stock from four different member states -- Ireland, Slovenia, Spain and the UK.

Three of these were atypical BSE, which is thought to occur spontaneously, but the other two were classical cases -- normally associated with consumption of contaminated feed.

The two classical cases were in animals born in 2010 (Ireland) and 2009 (the UK) some 14 and 13 years respectively after the enforcement of the feed ban in these countries.

While the number of cases is tiny when compared to the thousands of animals infected at the height of the BSE crisis, there has been little change over the past three years.

Previous annual reports – produced by the European Commission – showed two cases of classical BSE were detected in 2013 and three in 2014, while atypical cases numbered five and eight respectively.

This may seem miniscule when considering number of cattle tested last year but for the countries affected, the impacts can still be serious.

Ireland saw its BSE status downgraded after last year’s outbreak and the same happened to France earlier this year.

Investigation underwayTo help solve the conundrum, the European Commission has tasked EFSA with finding out the origin of recent classical cases. The agency is expected to produce a scientific opinion on the issue by the middle of next year. An EFSA working group held its first meeting in September and a follow-up is being held this week in Parma, Italy.

When requesting the study in May, Ladislav Miko, the Commission’s deputy director general for food safety, noted that EU regulations should prevent infection through the contaminated feed route.

The EU banned the use of processed animal proteins in ruminant feed as long ago as 1994, with a wider total feed ban extending to all farmed animals in 2001.

Mr Miko said it was hard to understand the origin of cases in animal born more recently. EFSA will now have to determine if contaminated feed can be ruled out and if so, whether there is enough scientific evidence to conclude that such cases had a spontaneous origin.

Either way, EFSA’s opinion could force a review of current approaches to the disease -- both at EU level and by extension on the wider international stage.

The OIE currently bases a country’s risk status on its history of classical BSE but effectively ignores atypical cases, which are thought to occur spontaneously in a small number of animals.

Max Green is the Meat and Livestock Editor for Agra Europe, a sister publication of Animal Pharm.

New Zealand launches 10-year biosecurity program

BY MALCOLM FLANAGAN

New Zealand has launched its nationwide biosecurity program for the next decade after consulting with the public for the past two years.

The Biosecurity 2025 Direction Statement was launched at a biosecurity forum in Auckland recently and follows particularly intense consultation earlier this year.

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The program has five key strategic elements. Minister for the country’s primary industries Nathan Guy said the first was to ensure by 2025 that at least 75% of adult New Zealanders understand biosecurity and why it is strategically important for the country’s rural and farm industries.

Other strategic targets to be reached by 2025 include:

• Having 90% of relevant businesses actively managing pests and disease risks;

• A publicly-accessible network that enables electronic access to organism data held by central government agencies, regional councils and Crown research institutes;

• Public and private investment of at least NZ$80 million ($57 million) in science for biosecurity, with at least 50% of the investment focused on critical biosecurity areas;

• and identifying 150,000 skilled people that can be quickly drawn on to support responses to biosecurity incursions including animal diseases.

Mr Guy said: “Biosecurity 2025 will guide New Zealand’s biosecurity system over the next decade. It provides a shared direction to ensure we can cope with increased disease challenges such as increasing trade, more complex markets and supply chains, and rising tourist numbers.

“The primary sector is a major part of our economy, making up around half of all our exports. This is why biosecurity and protecting our producers from unwanted pests and diseases has always been my number one priority.

“What we’ve got now is a roadmap to achieve important goals around raising public awareness of biosecurity, getting people to take action, making smarter use of information and having the best tools, rules and processes.”

In October this year, New Zealand said it would set stricter rules, including an accreditation scheme, for the growing number of cruise ships visiting the country.

The scheme involves collecting background information about vessel stores to determine biosecurity risks to animals, humans and crops.

The trial scheme also involves getting assurances from cruise lines that vessels have strict systems for pest and disease control. The initiative also aims to ensure vessels actively promote biosecurity messages, such as restrictions on carrying fruit fly-host materials like bananas and apples.

Dog anxiety disorders common in Australia

BY MALCOLM FLANAGAN

A leading Australian canine expert said recently anxiety disorders are common ailments among the country’s dogs.

Dr Gaille Perry told members of the Australian Veterinary Association (AVA) at a companion animal conference in Perth, Western Australia, the best way to manage anxiety in dogs was to be able to recognize and diagnose it speedily.

Dr Perry said stress plays a key role in the development of many anxiety-related conditions. There may be a genetic propensity to develop anxiety, but learning also plays a major part.

“Anxiety is a medical condition and if an owner suspects that their pet is displaying signs of the disorder, they should speak to their veterinarian as soon as possible so that a diagnosis can be made and a treatment plan can begin,” said Dr Perry.

She warned punishment should never be used when training an anxious dog as it only further increases the anxiety and impedes learning of the desired behavior. She also said every case is different and if medication is required, the type and dose should be based on the individual needs of each patient. There are an estimated 4.2 million dogs in Australia.

“Medication is used to improve an imbalance in the animal’s neurochemistry, to normalize the animal. It will not solve the problem, it merely assists us to modify the pet’s behavior,” Dr Perry said.

“Medication can be used over longer periods (six to nine months or more) or in the short term which will work to reduce anxiety quickly during or before events that trigger anxious behavior.”

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Dr Perry told AVA delegates anxiety-related behavioral problems also extend to cats. A common behavioral problem in cats is urine spraying, which is an anxiety-related issue and often requires medication and management. There are 3.3 million cats in Australia.

Integrated Animal Health adds to board

BY JOSEPH HARVEY

Integrated Animal Health (IAH) has added Walt George and Chuck Stephens to its board of directors as it expands its expertise in the US.

Mr George has over 35 years of experience in the consumer packaged goods sector, including the pet food industry. He founded G3 Consulting in Fairway, Kansas, to provide advisory services to small and mid-market companies.

He has previously served as president of the American Italian Pasta Company and held a number of leadership positions with Hill’s Pet Nutrition. Notably, he is also chairman of the board of trustees for the Morris Animal Foundation.

Mr Stephens is founder, president and chief executive of Stephens & Associates Advertising, which is based in Overland Park, Kansas. His firm is a branding company formed in 1980 and focused on the animal health sector. Mr Stephens was also one of the founders of Banfield, the first network of pet hospitals.

IAH’s other board members are Dr Blake Hawley, the firm’s president and chief executive, and Rob Neely, who is the company’s founder and executive chairman.

The Lawrence, Kansas-based business originated in Australia. However, the firm is growing its presence and team in the US after moving its global headquarters to the Bioscience & Technology Business Center at the University of Kansas last year. Mr Neely recently explained the reasoning behind IAH’s relocation from Australia to the US.

Delacon strengthens sales team in China

BY MALCOLM FLANAGAN

Austrian feed additive specialist Delacon Biotechnik is expanding its team in China with the addition of two more animal health experts to service customers in the region.

Steyregg-headquartered Delacon said it has appointed Allen Song as technical sales manager for China and Nick Wang as sales manager for north China.

Mr Song joined Delacon as new technical manager China with strong focus on monogastric animals. Prior to Delacon, he served as technical support and sales manager at Shandong Longlive Biotechnology and worked in quality assurance at Chinwhiz Agribusiness.

Delacon said the latter is among the top 10 feed additive companies in China. During his master degree studies in animal nutrition (swine) and feed technology at the Shandong Agricultural University, Mr Song focused on phytogenic feed additives.

Mr Wang is supporting the Delacon team as sales manager for North China. For the last five years, he has served as the regional senior sales for the bovine product line of Beijing IDEXX Yuanheng Laboratories.

Mr Wang studied biotechnology at the Shandong University and has a master’s degree in clinical veterinary sciences from the Beijing University of Agriculture. Both appointees will be based in Shanghai.

Stephane Jolain, director of global sales and marketing for Delacon, said: “With his technical know-how, his passion for phytogenic feed additives, and his strong relationships with nutritionists and customers, both in China and foreign countries, Mr Song will technically support our Chinese Sales team concerning Fresta and Biostrong products.

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“As for ruminants, Mr Wang has sound experience in dairy business and will have special focus on Actifor products. Furthermore, his deep knowledge about the Chinese dairy market and his established network will help to further promoting phytogenic feed additives.”

The company founded its China head office in Shanghai in 2010 and has been increasing it sales and customer services in the region since. Delacon claims to be the global leader in phytogenic products.

In August this year, Delacon selected a Chinese agronomist to lead research and development within its poultry and immunology department.

The company said Dr Emily Zhou will support the team of Dr Andreas Mueller, the overall head of R&D for the company. Delacon runs its own research center, the Performing Nature Research Center (PNRC) in Znaim, the Czech Republic. Besides the collaboration with experts and scientists from independent institutions all around the world, the PNRC is used to examine the efficacy of phytogenic substances applied in animal feed.

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